Device recall
Z-0325-2016: Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0325-2016 |
|---|---|
| Recall event | 69127 |
| Product | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. |
| Product code | LNH |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2021 |
| 510(k) numbers | K063559, K110151 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database